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NCT Number: NCT00644904

Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple Sclerosis

Vitamin D likely plays a role in the geography of Multiple Sclerosis (MS), and patients at risk and with MS have relatively low Vitamin D levels compared to their normal counterparts.

This trial examines the safety of high dose oral Vitamin D3 titrated up to a maximum of 40,000 IU per day over a 12 month period. Fifty patients matched for MS and non-MS characteristics will be divided into two groups: one group receiving the high dose Vitamin D regimen, and the other restricted to a maximum of 4000 IU per day. The hypothesis is that patients with MS can tolerate seemingly high doses of Vitamin D3 without adverse events and/or calcium-related abnormalities. It is also hypothesized that those receiving the higher doses will demonstrate improved relapse and disability status compared to controls, and that the treatment group will show improved markers of bone health and immune indicators of reduced inflammation.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically definite MS
  • Age 18-55
  • EDSS 0-6.5

Exclusion criteria

  • EDSS => 7.0
  • Current Vitamin D3 use >4000 IU/d
  • Baseline (25(OH)D) level <20 mmol/L (frank deficiency) and >150 mmol/L
  • Pregnancy or inability/unwillingness to use contraception
  • History of cardiac arrhythmia
  • History of renal disease and nephrolithiasis
  • History of granulomatous disease or lymphoma
  • Relapse activity or steroid use in the past 60 days

Treatment and study plan

Vitamin D3

Dietary Supplement

Primary outcomes

  1. Serum calcium

    Time frame: at each dose change

Secondary outcomes

  1. Serum 25(OH)D

    Time frame: at each dose change

  2. EDSS

    Time frame: at screening vs. end of trial

  3. N-telopeptide (bone marker)

  4. ALP/AST/ALT

    Time frame: at each dose change

  5. Creatinine/urea

    Time frame: at each dose change

  6. EKG

    Time frame: at screening and end of trial

  7. Renal ultrasound

    Time frame: at screening, mid-trial and end of trial

  8. Cytokine profile/MMP/lymphocyte response assay

  9. Annualized relapse rate

    Time frame: year prior to trial versus year of trial

  10. PTH

    Time frame: at each dose change

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Direct MS-Proactive Charity
  • Multiple Sclerosis Society of Canada

Registry information

Official study title

A Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple Sclerosis

Acronym: VitD4MS

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 27, 2008
Registry last updated
Mar 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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